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Healthy Skepticism Library item: 18213

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Electronic Source

Edwards J
Cephalon's Lollipops of Death: 56 Patients at One Clinic Die of Off-Label Painkiller Use
BNet 2010 Jun 11
http://industry.bnet.com/pharma/10008525/cephalons-lollipops-of-death-56-patients-at-one-pain-clinic-died-of-actiq-overdoses/


Full text:

A Kansas case in which a doctor is accused of unlawfully prescribing Cephalon (CEPH)’s Actiq painkiller among other drugs, leading to the fatal overdoses of fifty-six patients, sheds some light on the damage that can be caused by unapproved “off-label” drug sales.

In 2007, Cephalon paid $425 million to the Department of Justice in a settlement for illegal promotion of Actiq, a plastic lollipop filled with highly addictive fentanyl. The company pled guilty to a single federal misdemeanor violation. That deal highlighted the business side of off-label sales: 80 percent of Actiq’s sales were off-label (it’s supposed to be for cancer pain) and the company was promoting it as “an ER on a stick.”

The indictment in the Kansas case, against Dr. Stephen Schneider and his wife, Linda, covers the human side, i.e. it describes who was on the other end of those sales. The Schneiders operated a “pill mill” that became so notorious among addicts that the doctor came to be known as “Schneider the writer,” prosecutors allege.

In addition to the 56 deaths, the Schneiders’ practice allegedly sent 94 patients to the emergency room with overdoses; all other doctors in the area sent fewer than five each. Schneider’s clinic was staffed with physician’s assistants who had no specific training in pain management, and they were given pre-signed prescription pads by Schneider, the feds claim.

The mother of Robin Geist-Wick, one of the alleged victims, is a defense witness for Schneider. She has testified that her daughter’s migraines were so bad she visited the ER 16 times before seeing Schneider, who was the only physician to provide her relief.

Geist-Wick’s father, Robert Wick, sees it differently. He’s suing both Schneider and Cephalon in a medical malpractice suit. That suit is not mentioned in Cephalon’s Q1 2010 10-Q filing with the SEC, in which the company is supposed to list any legal action that might have a material effect on its finances. I guess Cephalon is confident its total liabilities in this matter are low.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909